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FDA 510(k)

Q5000 STRESS TEST MONITOR

K-Number: K864504 · 1987-04-09

ApplicantQuinton, Inc.
Decision Date1987-04-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Q5000 STRESS TEST MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1987-04-09 under 510(k) number K864504. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q5000 STRESS TEST MONITOR?

Q5000 STRESS TEST MONITOR is a medical device that received FDA 510(k) clearance on 1987-04-09. The listed applicant is Quinton, Inc.. The 510(k) number is K864504.

When did Q5000 STRESS TEST MONITOR receive FDA 510(k) clearance?

Q5000 STRESS TEST MONITOR received FDA 510(k) clearance on 1987-04-09, under 510(k) number K864504.

Who is the listed applicant for Q5000 STRESS TEST MONITOR?

The FDA 510(k) record lists Quinton, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q5000 STRESS TEST MONITOR?

The FDA product code for Q5000 STRESS TEST MONITOR is DPS.

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Other records listing Quinton, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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Related Devices (Code: DPS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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